Other safety alerts
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| The United States: Brintellix (vortioxetine): Drug Safety Communication - Brand name change to Trintellix, to avoid confusion with antiplatelet drug Brilinta (ticagrelor) |
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The Food and Drug Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.
Because of the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period.
Brintellix/Trintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder in adults. It is in a class of antidepressants called serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced.
In a July 2015 MedWatch Alert, FDA warned that name confusion between Brintellix and Brilinta had resulted in prescribing and dispensing errors since Brintellix was approved in September 2013. Due to continued reports of name confusion between the two medicines used for very different purposes, FDA worked with Brintellix manufacturer Takeda Pharmaceuticals to change the drug’s brand name.
Health care professionals should check carefully to make sure they have prescribed or dispensed the correct medicine. During the transition to the new name change from Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. Patients should make sure they have received the correct medicine. Trintellix tablets will look the same as the Brintellix tablets. Those having any questions or concerns should talk to their prescriber or pharmacist.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm498607.htm
In Hong Kong, Brintellix Tablets 5mg (HK-63601), Brintellix Tablets 10mg (HK-63600) and Brintellix Tablets 20mg (HK-63599) are pharmaceutical products registered by Lundbeck Export A/S (Lundbeck); while Brilinta Tab 90mg (HK-61187) is a pharmaceutical product registered by AstraZeneca Hong Kong Ltd. All products are prescription only medicines. Related news was previously issued by the FDA, and was posted on the Drug Office website on 31 July 2015. Letters to inform local heatlhcare professionals were also issued on the same day. So far, the Department of Health (DH) has received one case of adverse drug reaction (ADR) on Brilinta, and it was not related to name confusion with Brintellix; while no ADR case has been received on Brintellix. In light of the latest FDA announcement on the product name change from Brintellix to Trintellix, DH will inform Lundbeck about the development, and will continue to follow-up the issue with Lundbeck.
Ends/ Tuesday, May 03, 2016
Issued at HKT 15:00
As informed by Lundbeck, at this stage, there are no agreements with, or regulatory request by overseas drug regulatory authorities, to change the name Brintellix in any countries other than the US. DH will remain vigilant on the incident.
Content last updated, Tuesday, May 17, 2016
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